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13.9 English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof and in the event of any conflict in interpretation between t... |
13.10 Equitable Relief. Each Party acknowledges and agrees that the restrictions and obligations set forth in Section 4.7, Section 8.1, and Article 9 are reasonable and necessary to protect the legitimate interests of the other Party and that such other Party would not have entered into this Agreement in the absence of... |
13.11 Specific Performance. Calibr acknowledges and agrees that Calibr's obligations set forth in Section 2.1.1, Section 2.1.2, Section 2.2.1, Section 2.6.1, Section 2.10, Section 5.3 and Section 10.3.5, are unique and that AbbVie would not have entered into this Agreement in the absence of such obligations, and that a... |
13.12 Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. Th... |
13.13 No Benefit to Third Parties. Except as provided in Article 11, the covenants and agreements set forth in this Agreement are for the sole benefit of the Parties and their successors and permitted assigns and they shall not be construed as conferring any rights on any other Persons. |
13.14 Further Assurance. Each Party shall duly execute and deliver or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may... |
13.15 Relationship of the Parties. It is expressly agreed that Calibr, on the one hand, and AbbVie, on the other hand, shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency, including for all tax purposes, and shall not take the po... |
13.16 HSR Act Compliance. If AbbVie determines that an HSR Filing is required with respect to AbbVie's exercise of the CD19 License Option or Platform Option, as applicable, the Parties shall cooperate to make an HSR Filing within fifteen (15) Business Days after (a) with respect to the CD19 License Option, the date up... |
13.17 References. Unless otherwise specified, (a) references in this Agreement to any Article, Section or Schedule shall mean references to such Article, Section or Schedule of this Agreement, (b) references in any Section to any clause are references to such clause of such Section and (c) references to any agreement, ... |
13.18 Construction. Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word "or" is used in the inclusive sense (and/or). Whenever this Agreement refers to a number of days, unless o... |
13.19 Amendment and Restatement. This Agreement constitutes an amendment and restatement of the Original License Agreement effective from and after the A&R Effective Date. All rights or obligations owing under the Original License Agreement, or based on facts or events occurring or existing prior to the A&R Effective D... |
13.20 Performance by Affiliates. AbbVie may use one (1) or more of its Affiliates to perform its obligations and duties hereunder and such AbbVie Affiliates are expressly granted certain rights herein; provided, that each such Affiliate will be bound by the corresponding obligations of AbbVie and, subject to an assignm... |
13.21 Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may be executed by facsimile, .pdf format via email or other electronically transmitted signatures and suc... |
[SIGNATURE PAGE FOLLOWS.] |
THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the A&R Effective Date. The Scripps Research Institute AbbVie Global Enterprises Ltd. By: [signature] Name: Peter G. Schultz Title: President/CEO By: [signature] Name: Azita Saleki-Gerhardt, Ph.D. Title: President [Signature Page to Amend... |
CD19 AUTOIMMUNE PLAN 2023-2025 This Work Plan summarizes the activities and deliverables for autoimmune preclinical and clinical research which may be optionally triggered by AbbVie through the CD19 Autoimmune Option. The goal of this work plan is to demonstrate the potential of the switchable CAR-T cell platform to be... |
Work Plan Initial CD19 Autoimmune Plan Period Covered Preclinical: models expected to be carried out over 2-3 years Clinical: expected to require approximately 3 years. Final timeline and number of patients are subject to discussion with AbbVie. Start date tbd (AbbVie option) Deliverable Preclinical: in vivo efficacy (... |
Outline of Work Plan: Background Early clinical studies have demonstrated efficacy of CART19 in lupus via "immune reset" (N Engl J Med 2021; 385:567). CAR-T mediated elimination of B cells expected to be more efficacious than targeting with monoclonal antibody due to depth of B cell depletion (elimination of autoreacti... |
[THIS IS FIGURE/CHART: A diagram showing a flow of concept development from "Potential to Establish CD19 sCAR-T as 'One Time Autoimmune Treatment'" through various phases of development and clinical applications] |
Preclinical (a) Calibr will perform additional studies to evaluate therapeutic effect of sCAR-T + CD19 in animal models of autoimmunity beyond lupus, which may include: a. Type 1 diabetes mellitus b. Multiple sclerosis c. Inflammatory bowel disease d. Rheumatoid arthritis (b) For each model, Calibr will perform a dose ... |
Clinical (a) Calibr will be responsible for carrying out a Phase I clinical study in subjects with lupus, including but not limited to regulatory, cell manufacturing, and operational activities. (b) Calibr and AbbVie will discuss and align on a clinical development plan for lupus which will include patient population. ... |
Schedule 1.80: CD19 Plan Activities related to Switch for CD19 program Calibr will conduct CD19 program |
Component Activities Requirements Data Deliverables Responsible Switch Production for pre-IND and IND Chevron 1 Development of formulation and manufacturing process, analytical testing and stability assessment for Fab switch per Agency requests. Manufacturing, testing, release and stability. Quality Oversight Label, sh... |
Tissue cross reactivity with anti-CD19 switch on panel of human tissues Chevron 2 Assess potential cross-reactivity of anti CD19 switch with panel of human tissues using immunohistochemical techniques. GLP study to be carried out with material from switch engineering or GMP run. Preparation of anti CD19 switch test art... |
IND enabling GLP Toxicology Study: A GLP study (or studies) in non-tumor bearing animals as guided by input from the FDA to assess the safety of the anti-CD19 switch will be conducted in the appropriate/ designated preclinical species. Chevron 3 Exact study design TBD and will be based on prior preclinical data and wit... |
Activities related to sCAR-T cells for CD19 Program |
Component Activities Requirements Data Deliverables Responsible Lentivirus Vector Product Manufacture Chevron 4 Transfer of packaging and transgene plasmids to CMO. Completion of GMP vector product manufacture to support nonclinical testing, cell manufacturing engineering run(s), release, stability and clinical trial. ... |
sCAR-T cell Process Development. Cell Production at CMO for IND Chevron 5 Process development and analytical development that demonstrates, robustness, reproducibility. Manufacturing, Release, Label, ship, etc. Development of processes for cell processing, cell culture, cell harvest, cryopreservation, stability, thaw a... |
Tissue cross reactivity with sCAR on panel of human tissues Chevron 6 Assess potential cross-reactivity of sCAR scFv with panel of human tissues using immunohistochemical techniques. GLP study. Preparation of the scFv of the sCAR as test article by expression of scFv-Fc fusion protein (or alternatively scFv-His tagged ... |
In vivo efficacy in Xeno model in NSG mice to support IND (Definitive mouse model aka GLP/ GLP-like model) Chevron 7 Assess in vivo activity of sCAR-T with anti-CD19 switch in appropriate preclinical efficacy model to support IND package. Efficacy analysis of sCAR-T to support IND package. Xenograft model will be NALM-... |
Clinical Regulatory for CD19 program |
Component Activities Requirements Data Deliverables Responsible pre- IND meeting with Agency Star 8 Establish communication with CBER on the CD19 preclinical, manufacturing, tox, and clinical plans through pre-pre IND interaction. Deliver to Agency: (i) Summary description of the intended clinical product (ii) Summary ... |
Clinical CRO contracting Chevron 9 Evaluate and select a clinical CRO to support the trial. Contracting the CRO and relevant third party vendors. Develop budget and timeline with the CRO and vendors. Scope to include management activities an integrated solutions services including but not limited to clinical operation ... |
pre- IND meeting with Agency Chevron 10 Receive formal feedback from CBER on CD19 program through pre-IND meeting. Deliver to Agency: (i) product name, IND number (ii) structure (iii) indication (iv) dosage form, ROA, regimen (v) list of attendees (vi) program background, preclinical, development, clinical strategy (vi... |
Clinical trial start-up, site initiation, and IRB review Chevron 11 Qualified clinical CRO to manage clinical start-up activities. Selection of qualified clinical sites and investigators to conduct the study. Conduct site initiation visits and CRA trainings. Obtain local or central regulatory approvals. Establish ICF, ... |
IND Chevron 12 Preparation of the IND package. Publish and eCTD submission to the FDA Deliver to Agency: Signed Form FDA 1571, Form FDA 1572 Statement of Investigator, Form FDA 3674 Certification of Compliance; (i) TOC (ii) Introductory statement and general investigational plan (iii) Investigator's brochure (iv) Clini... |
CMC documentation Chevron 12 CMC reports, data and records that describe process / method development. Records pertaining to GMP manufacture, testing, and lot release CTD sections and CMC reports, including letters of cross reference to BMFs Calibr to prepare IND documentation. |
Phase I clinical trial execution Chevron 13 Calibr to conduct phase I clinical study for CD19 program through the clinical CRO. Manufacture and supply CAR-T cell products to patients. Enroll and treat patients under GCP guidelines. Monitor and report SAE to regulatory authorities. Conduct interim onsite monitoring visi... |
Clinical study report publishing and submission Chevron 14 Compilation of a core clinical study report Data package that include tables, listings figures, and datasets, interim and draft Clinical Study Report. Calibr to review and approve TLF and report. Calibr responsible for oversight over clinical CRO and delivery o... |
Key CMC goals: CAR Lentivirus intermediate: • Timing for GMP manufacturing - Aug/Sept 2018 • Timing for Release - Jan/Feb 2019 • Expected yield - ≥ 50 mL of 107-108 TU/mL CD19 switch DS: • Timing for GMP manufacturing - Nov 2018 • Timing for Release - Jan 2019 CD19 switch DP: • Timing for GMP manufacturing - Jan 2019 •... |
1.80 – CD19 Clinical synopsis: Protocol Number CBR-CLBR001/SWI019-3001 |
Title A PHASE 1, OPEN-LABEL STUDY OF THE COMBINATION OF CLBR001, AN ENGINEERED AUTOLOGOUS T-CELL PRODUCT, AND SWI019, AN ANTIBODY-BASED BIOLOGIC, IN PATIENTS WITH CD19+ FOLLICULAR LYMPHOMA |
Sponsor CALIBR |
Name of Investigational Product CLBR001 (Cellular Product) Chimeric antigen receptor T (CAR-T) cell product that comprises the patient's T cells and a novel "switchable" chimeric antigen receptor (sCAR-T), code name ENH655. From extracellular to intracellular, the ENH655 structure consists of an scFv followed by an IgG... |
Phase 1 |
Investigator/Study Center TBD |
Objectives: Primary Objective • To determine the safety and tolerability of CLBR001 • To determine the maximum tolerated dose (MTD) of SWI019 when administered intravenously after administration of CLBR001 |
Secondary Objectives • To measure the depletion of B cells in response to dose escalation of SWI019 switch after administration of CLBR001 • To measure serum cytokines in response to dose escalation of SWI019 switch after administration of CLBR001 • To determine the in vivo survival and expansion or elimination of CLBR... |
Exploratory Objective • To assess exploratory biomarkers, including markers of immune function and inflammatory pathways |
Number of Subjects Total enrollment is approximately 36 patients |
Study Design and Methodology Single-arm, open-label, dose-escalation, Phase 1 study in patients with CD19+ Follicular Lymphoma. Sentinel dosing will be applied in all dose cohorts. |
At entry subjects will be staged and the suitability of their T cells for CAR-T manufacturing will be determined. Subjects who have adequate T cells will undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC) for CART manufacturing. From a single leukapheresis, the intention is to harvest at least [x... |
The T cells will be purified from the PBMC, transduced with ENH655 lentiviral vector (LV01-ENH655), expanded in vitro and then frozen for future administration. Cytoreductive chemotherapy will then be given. Following tumor burden reassessment, CLBR001 cells will be thawed and infused. SWI019 will be infused separately... |
Cohort 1, 2 and 3 Dose cohort 1, 2 and 3 will receive a fixed single IV dose of CLBR001 at 1x106 cells/kg on D1. Dose Cohort 1 The switch dose SWI019 will follow an accelerated titration scheme, i.e. four days after the administration of CLBR001 (D5) patients will receive SWI019 at a starting dose of 1/10th of the EC50... |
Dose Cohort 2 The switch dose SWI019 will follow an accelerated titration scheme, i.e. four days after the administration of CLBR001 (D5) patients will receive SWI019 at a starting dose of 1x MABEL, followed by 3x MABEL on D7, 9x MABEL on D9, and four doses of 9x MABEL on D11, D13, D15 and D17. |
Dose Cohort 3 The switch dose SWI019 will follow an accelerated titration scheme, i.e. four days after the administration of CLBR001 (D5) patients will receive SWI019 at a starting dose of 3x MABEL, followed by 9x MABEL on D7, 27x MABEL on D9, and four doses of 27x MABEL on D11, D13, D15 and D17. |
Patients will subsequently enter a recovery period of 11 days, from D18 to D28. Cohort 4, 5 and 6 Dose cohort 4, 5 and 6 will receive a fixed single IV dose of CLBR001 at 5x106 cells/kg on D1. Dose Cohort 4 |
The switch dose SWI019 will follow an accelerated titration scheme, i.e. four days after the administration of CLBR001 (D5) patients will receive SWI019 at a starting dose of 1/10th of the EC50 based MABEL, followed by 1x MABEL on D7, 3x MABEL on D9, and four doses of 3x MABEL on D11, D13, D15 and D17. |
Dose Cohort 5 The switch dose SWI019 will follow an accelerated titration scheme, i.e. four days after the administration of CLBR001 (D5) patients will receive SWI019 at a starting dose of 1x MABEL, followed by 3x MABEL on D7, 9x MABEL on D9, and four doses of 9x MABEL on D11, D13, D15 and D17. |
Dose Cohort 6 The switch dose SWI019 will follow an accelerated titration scheme, i.e. four days after the administration of CLBR001 (D5) patients will receive SWI019 at a starting dose of 3x MABEL, followed by 9x MABEL on D7, 27x MABEL on D9, and four doses of 27x MABEL on D11, D13, D15 and D17. |
Patients will subsequently enter a recovery period of 15 days, from D14 to D28. Cohort 7, 8 and 9 Dose cohort 7, 8 and 9 will receive a fixed single IV dose of CLBR001 at 25x106 cells/kg on D1. Dose Cohort 7 The switch dose SWI019 will follow an accelerated titration scheme, i.e. four days after the administration of C... |
Dose Cohort 8 The switch dose SWI019 will follow an accelerated titration scheme, i.e. four days after the administration of CLBR001 (D5) patients will receive SWI019 at a starting dose of 1x MABEL, followed by 3x MABEL on D7, 9x MABEL on D9, and four doses of 9x MABEL on D11, D13, D15 and D17. |
Dose Cohort 9 The switch dose SWI019 will follow an accelerated titration scheme, i.e. four days after the administration of CLBR001 (D5) patients will receive SWI019 at a starting dose of 3x MABEL, followed by 9x MABEL on D7, 27x MABEL on D9, and four doses of 27x MABEL on D11, D13, D15 and D17. |
Patients will subsequently enter a recovery period of 15 days, from D14 to D28. Cohorts 1 - 9 Dosing with the switch SWI019 will continue for 3 cycles (for a total of 4 cycles). Patients will have the option to continue dosing with SWI019 until either disease progression is confirmed or an unacceptable toxicity occurs. |
The study will be conducted at two sites, using a 3+3 rule-based design. The number of cohorts is 9, with an approximate total number of 36 (27+9) patients based on a 30% drop-out rate. The final sample size depends on the number of doses explored, tumor progression, the number of patients with DLTs, and the actual num... |
A Data Safety and Monitoring Board (DSMB) will provide data and safety oversight at each participating site following the policy of the National Cancer Institute (NCI) for data and safety monitoring of clinical trials. Patients may be replaced if they do not reach the Day 28 visit due to non-DLT events (eg, disease pro... |
Safety Definitions and Rules Definitions of DLT and MTD: DLT is defined as any of the following: • Grade 4 leukopenia (WBC < 1,000/μl) lasting 28 days or more from the time of infusion (in patients with a pre-treatment WBC of > 1,000/μl) unless due to persistent disease. • Grade 3 or 4 thrombocytopenia that fails to re... |
Cytokine Release Syndrome |
Management of Cytokine Release Syndrome (CRS) Following infusion of xxxx cells and SWI019 switch, patients may develop severe CRS. The development of severe CRS has only been observed in patients with morphologic evidence of disease (>5% blasts in BM) at the time of CAR-T cell infusion. |
Severe CRS is defined by the presence of one of the following clinical and laboratory parameters: • Hypotension: SBP<90 refractory to IV fluids or requiring at least one vasopressors • Respiratory distress/hypoxia requiring increasing supplemental oxygen or ventilator support • Acute coronary syndrome (ACS) with positi... |
Stopping Rules for Delayed Toxicity: Dose escalation will proceed based on DLT experienced within the treatment and observation periods as described in "Definitions of DLT and MTD" (above) after four to six weeks that are related to treatment with gene-modified T cells will be evaluated by the investigators and reporte... |
Management of Infusion-Related Reactions T cell infusion may be continued at the same dose and rate of administration if a grade 1 infusion-related reaction occurs. Fever, chills, and rigors may be treated with acetaminophen 325 to 650 mg by mouth, diphenhydramine 12.5 to 50 mg intravenously or by mouth, meperidine 12.... |
Treatment may be continued with a 50% reduction in the infusion rate if a grade 2 infusion-related reaction occurs. Symptoms may be treated as above and/or as clinically indicated. |
The infusion of T cells will be stopped if a grade 3 infusion-related reaction occurs. Symptomatic treatment, as outlined above, will be administered as necessary and the infusion can be resumed at a 50% rate reduction after resolution of symptoms. T cell infusion will be discontinued if a grade 3 reaction recurs after... |
In addition, T cell infusion will be discontinued if a grade 4 infusion-related toxicity occurs. Symptoms will be treated using the guidelines above and no further T cells will be infused. |
Study Population: B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of non-Hodgkin's lymphomas (NHL), acute lymphoblastic leukemias (ALL) and chronic lymphocytic leukemias (CLL). An estimated 80,500 new cases of Hodgkin's and non-Hodgkin's lymphomas are diagnosed in the US in 201... |
Follicular lymphoma (FL) is the second most frequent non-Hodgkin lymphoma accounting for about 10-20% of all lymphomas in western countries. In the United States, FL accounts for approximately 35 percent of NHLs and has an estimated incidence of 3.18 cases per 100,000 people. The incidence increases with age; FL most f... |
While FL is usually viewed as a disorder with an indolent clinical course, the recently published m7-FL International Prognostic Index (m7-FLIPI) allows for stratification of FL patients into risk groups according to progression of disease within 24 months, based on a clinicogenetic risk model assessment of the mutatio... |
CD19 is a 95kDa glycoprotein present on B cells from early development until differentiation into plasma cells. It is a member of the immunoglobulin (Ig) superfamily and a component of a cell surface signal transduction complex that regulates signal transduction through the B cell receptor. Mice lacking CD19 have a dec... |
Chimeric antigen receptor T (CAR-T) cell therapy is an emerging class of immunotherapy based on engineered autologous T-cells that has been proven to be an effective treatment in refractory/relapsing ALL and large B-cell lymphoma. However, these therapies are associated with significant risks to patients including cyto... |
To be eligible, the subjects must have an adequate number of T cells that can be successfully transduced and expanded with the anti-CD19 lentivirus vector, as determined from a sample of PBMC obtained by phlebotomy at the first screening visit (~week -8). The purpose of this screening procedure is to exclude subjects f... |
Female subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure [hysterectomy or bilateral oophorectomy]) must have a negati... |
Due to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subje... |
Acceptable birth control includes a combination of two of the following methods: • Condoms* (male or female) with or without a spermicidal agent. • Diaphragm or cervical cap with spermicide • Intrauterine device (IUD) • Hormonal-based contraception |
Subjects who are not of reproductive potential (women who have been post menopausal for at least 24 consecutive months or have undergone hysterectomy, salpingotomy, and/or bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception. Acceptable documentation of ... |
Inclusion Criteria: Diagnosis and main criteria for inclusion: Patients must meet the following criteria to be enrolled in this study: |
Male and female subjects with CD19+ B cell malignancies, including subjects with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to <2 year survival) with currently available therapies will be enrolled: 1. Follicular Lymphoma (FLL) a) m7-FLIPI hi... |
2. Age > 18 years. 3. Expected survival > 12 weeks 4. Creatinine < 2.5 mg/dl. 5. ALT/AST < 3x normal 6. Bilirubin <2.0 mg/dl 7. Any relapse after prior autologous SCT will make patient eligible regardless of other prior therapy. 8. Adequate venous access for apheresis, and no other contraindications for leukapheresis. ... |
Exclusion Criteria: Any patient who meets any of the following criteria will not qualify for entry into the study: 1. Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed ... |
Study Endpoints: Primary Endpoints: Primary safety, feasibility and engraftment endpoints include: 1. Occurrence of study related adverse events, defined as NCI CTC > grade 3 signs/symptoms, laboratory toxicities and clinical events that are possible, likely or definitely related to study treatment. This will include i... |
Secondary Endpoints: 1. Duration of in vivo survival of CLBR001 cells is defined as "engraftment". The primary engraftment endpoint is the # DNA vector copies per ml blood of CLBR001 cells on week 4 after the first infusion. Q-PCR for CLBR001 vector sequences will also be performed after infusion at 24 hours, weekly x ... |
Exploratory Endpoints: |
Investigational Product, Dose and Mode of Administration: The investigational product is a combination of • CLBR001 cells, which are autologous T cells that have been engineered to express an extracellular single chain antibody (scFv) with specificity for SWI019, linked to an intracellular signaling molecule comprised ... |
Reference Therapy, Dose and Mode of Administration: None |
Study Duration The study is planned to start in Q2-3/2019, study recruitment is planned to be completed in Q3-4/2020. Patients will be offered the choice to continue dosing with SWI019 until disease progression is confirmed or an unacceptable toxicity occurs. |
Criteria for Evaluation: Pharmacokinetics of SWI019: Pharmacokinetic parameters will include: • Systemic clearance • Maximum observed serum concentration (Cmax) • Time to reach Cmax after drug administration • Minimum concentration at the end of a dosing interval • Terminal elimination half-life • Volume of distributio... |
Immunogenicity The status of the anti-SWI019 antibody (ADA response) will be determined for all patients. Assay results will be reported as positive or negative for the confirmatory and in neutralizing assays. The proportion of patients with positive results will be summarized. |
Pharmacodynamics: Pre- and post-treatment peripheral blood samples and bone marrow biopsies will be collected to assess the penetrance of CLBR001/ SWI019 in patients. The pharmacodynamic assessments of tumor biopsies may include, but are not limited to, SWI019 binding to CD19 and CLBR001, and presence of activated T-ce... |
Exploratory Biomarkers: Pre- and post-treatment peripheral blood samples will be collected to assess levels of serum cytokines and chemokines including but not limited to: IL-2, TNFa, IL-6, IFNg, MIP1a, MIP1b, sgp130, sIL6R, MCP-1. A panel of clinical laboratory tests for chemistries as well as C-reactive protein (CRP)... |
Efficacy Evaluations Efficacy of CLBR001/ SWI019 in FL patients will be evaluated as a secondary endpoint using endpoints of objective responses (OR). For this study, classification of response will be either Minimal Residual Disease (MRD), Overall Remission Rate (ORR), which includes Complete Remission (CR, with full,... |
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